Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322881
Status:
TERMINATED
Last Update Posted:
2018-09-10
First Post:
2006-05-05
Brief Title:
Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian Peritoneal or Fallopian Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian Peritoneal or Fallopian Cancer
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early closure based on audit by study investigators after 3 patients died on study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this trial is to look at how elderly women 70 years of age or older with newly diagnosed ovarian peritoneal or fallopian tube cancer manage six cycles of carboplatin and paclitaxel what side effects they experience and how their cancer reacts or responds to standard carboplatin and paclitaxel chemotherapy
Detailed Description:
OBJECTIVES
Primary
To determine the completion rate of six cycles of carboplatinpaclitaxel with no dose reductions because of toxicities
Secondary
Assess cancer antigen 125 CA125 response rates of paclitaxelcarboplatin in this group of patients
Assess significant toxicities in this group of patients and compare to a non-elderly population
To determine which clinical parameters will predict lack of completion of six cycles of carboplatin and paclitaxel chemotherapy
Assess quality of life changes during chemotherapy and up to one year after completion of chemotherapy
Assess progression-free survival and overall survival for this group
To determine the feasibility of accrual
STATISTICAL DESIGN
Using a one sample binomial design with 37 patients there was 83 power to detect a null hypothesis of a 45 therapy completion rate versus an alternative hypothesis of a 66 rate assuming a one-sided 5 alpha The regimen would be declared ineffective if there were 19 or fewer patients who completed 6 cycles of carboplatin and paclitaxel chemotherapy without dose adjustments
Primary
To determine the completion rate of six cycles of carboplatinpaclitaxel with no dose reductions because of toxicities
Secondary
Assess cancer antigen 125 CA125 response rates of paclitaxelcarboplatin in this group of patients
Assess significant toxicities in this group of patients and compare to a non-elderly population
To determine which clinical parameters will predict lack of completion of six cycles of carboplatin and paclitaxel chemotherapy
Assess quality of life changes during chemotherapy and up to one year after completion of chemotherapy
Assess progression-free survival and overall survival for this group
To determine the feasibility of accrual
STATISTICAL DESIGN
Using a one sample binomial design with 37 patients there was 83 power to detect a null hypothesis of a 45 therapy completion rate versus an alternative hypothesis of a 66 rate assuming a one-sided 5 alpha The regimen would be declared ineffective if there were 19 or fewer patients who completed 6 cycles of carboplatin and paclitaxel chemotherapy without dose adjustments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None